Pfizer Inc. recalls HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira,
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Recall notice
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
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Source Page by GovInfoNow · govinfonow.com/recall/41353-pfizer-inc-recalls-hydromorphone-hcl-injection-usp-2-mg-ml · Recall date August 22, 2017 · FDA enforcement record: FDA #D-1167-2017
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“Pfizer Inc. recalls HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira,.” GovInfoNow, recall dated August 22, 2017. https://govinfonow.com/recall/41353-pfizer-inc-recalls-hydromorphone-hcl-injection-usp-2-mg-ml. Based on FDA recall #D-1167-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1167-2017%22&limit=1).
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- Brand
PFIZER INC- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
United States Nationwide (including Puerto Rico) and Singapore
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1167-2017 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial); Lot: 760853A | 115,370 vials | 0409-2552-11, 0409-2552-01, 0409-3356-11, 0409-3356-01, 0409-2540-11, 0409-2540-01, 0409-3365-11, 0409-3365-01, 0409-3365-10, 0409-1283-03, 0409-1283-31, 0409-1312-03, 0409-1312-30, 0409-1304-03, 0409-1304-31 |
| D-1168-2017 | Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04; Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18 | 98,050 vials | 0409-3375-14, 0409-3375-04, 0409-1443-14, 0409-1443-04 |
Contact PFIZER INC
We’ve drafted a message you can send PFIZER INC to request your refund or repair — edit it as you like.
Subject: Recall D-1167-2017 — PFIZER INC Pfizer Inc. recalls HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, pack Hello, I own a Pfizer Inc. recalls HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, that is covered by recall D-1167-2017 from PFIZER INC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1167-2017 (August 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1167-2017 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.